The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

NCT ID: NCT04810793

Last Updated: 2022-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

820 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-06-30

Brief Summary

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The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Detailed Description

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Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer.

At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment in patients with Hp eradication failure.

Conditions

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Helicobacter Pylori

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group

Patients in amoxicillin-levofloxacin-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.

Amoxicillin , Levofloxacin and Esomeprazole

Intervention Type DRUG

Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens

Amoxicillin-Furazolidone-Esomeprazole-containing quadruple group

Patients in amoxicillin-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

Amoxicillin , Furazolidone and Esomeprazole

Intervention Type DRUG

Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens

Tetracycline-Furazolidone-Esomeprazole-containing quadruple group

Patients in tetracycline-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

Tetracycline , Furazolidone and Esomeprazole

Intervention Type DRUG

Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens

Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group

Patients in amoxicillin-levofloxacin-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.

Amoxicillin,Levofloxacin and Vonoprazan fumarate

Intervention Type DRUG

Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group

Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group

Patients in amoxicillin-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

Amoxicillin,Furazolidone and Vonoprazan fumarate

Intervention Type DRUG

Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group

Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

Patients in tetracycline-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

Tetracycline,Furazolidone and Vonoprazan fumarate

Intervention Type DRUG

Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

Interventions

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Amoxicillin , Levofloxacin and Esomeprazole

Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens

Intervention Type DRUG

Amoxicillin , Furazolidone and Esomeprazole

Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens

Intervention Type DRUG

Tetracycline , Furazolidone and Esomeprazole

Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens

Intervention Type DRUG

Amoxicillin,Levofloxacin and Vonoprazan fumarate

Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group

Intervention Type DRUG

Amoxicillin,Furazolidone and Vonoprazan fumarate

Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group

Intervention Type DRUG

Tetracycline,Furazolidone and Vonoprazan fumarate

Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taian City Central Hospital

OTHER

Sponsor Role collaborator

Dezhou People's Hospital

OTHER

Sponsor Role collaborator

Weifang Medical University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Shengli Oilfield Hospital

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Xiuli Zuo

Professor, Director of gastroenterology department of Qilu hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiuli Zuo, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2020-SDU-QILU-G101

Identifier Type: -

Identifier Source: org_study_id

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